MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

Device is expected but has not yet been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s5 double head pump displayed an error message during set-up.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the s5 double head pump displayed an error message during set-up.There was no patient involvement.

Manufacturer Narrative

Livanova deutschland manufactures the s5 double head pump.The incident occurred in (b)(4).This medwatch report is being filed on behalf of livanova deutschland.The s5 circuit board was returned to livanova deutschland for further investigation.Investigation determined the problem was caused by a faulty transistor t2.For safety measure the pcb was scrapped.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As per e-mail from (b)(4) dated 9 feb 2021 livanova is submitting this follow-up in replacement of the already provided medwatch 9611109-2015-00962 due to the fact that the reference provided was incorrect.

Event Description

See initial report submitted outside of reliance (mfr 9611109-2015-00596).

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich,
• MDR Report Key: 5317090
• MDR Text Key: 34075243
• Report Number: 9611109-2015-00596
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1